Method and apparatus for long-term assisting a left ventricle to pump blood

ABSTRACT

A method and apparatus for long-term assisting the left ventricle of a heart to pump blood is disclosed which includes at least one transluminally deliverable pump and a transluminally deliverable support structure which secures the at least one pump within the aorta for long-term use.

RELATED APPLICATIONS

This application claims the benefit and priority of U.S. PatentApplication Ser. No. 60/601,733 filed Aug. 13, 2004, and 60/653,015filed Feb. 15, 2005.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a method and apparatus for long-term assistingthe left ventricle of a heart to pump blood. A left ventricle assistdevice and associated methods are disclosed.

2. Description of the Related Art

With the advent of new drugs, percutaneous transluminal coronaryangioplasty, commonly known as “balloon angioplasty” and the use ofstents in combination with balloon angioplasty, effective treatments areavailable for heart disease, as it relates to coronary arteries. Themajor problem currently in treatment of heart disease is treatingindividuals having congestive heart failure or who may require a hearttransplant. In this regard, it is believed that only certain very illpatients may require a heart transplant, whereas many other individualswith heart disease could benefit from a less complicated, costly, andinvasive procedure, provided the individual's heart can be somehowassisted in its function to pump blood through a person's body.

To this end, left ventricle assist devices (“LVAD”) are in current usethat can boost the heart's pumping ability, without replacing thepatient's heart by way of a heart transplant. While presently availableleft ventricle assist devices do provide a benefit to patients withheart disease who require either a heart transplant or assistance inpumping blood throughout the body, it is believed that currentlyavailable devices have certain disadvantages associated with them.Conventional left ventricle assist devices generally require surgeryupon the heart itself, including surgical incisions into the heart,which may weaken the heart, as well as requires a complicated procedureto implant the left ventricle assist device.

Most LVAD implantations require a midline sternotomy of the chest andutilization of cardiopulmonary bypass. Newer devices can be implantedthrough a lateral thoracotomy and can be done without usingcardiopulmonary bypass; however, large loss of blood may occur duringthis procedure. It is also important to note the fact that all currentlong term LVAD devices require operation on the heart itself anddisruption of the myocardium, which can lead to further problems,including arrhythmias, and left and right ventricular dysfunction, whichcan lead to poor outcomes in the patients. The major disadvantage intreating patients with chronic congestive heart failure through asurgical approach is that there is a significant risk of the surgeryitself, including just the use of general anesthesia itself and the useof the heart lung machine. Patients with chronic congestive heartfailure have impaired liver, renal, pulmonary and other organ function,and therefore, are prone to multiple complications following surgery. Asa result, current long-term implantable left ventricular assist deviceshave a one-year mortality rate of greater than 30%.

Currently available left ventricle assist devices may include pumpsplaced within the left ventricle of the heart. Currently availabledevices typically include relatively long conduits, or fluidpassageways, in fluid communication with the heart, and through whichthe person's blood must flow and be pumped therethrough. It is believedthat the long conduits may become sites for thrombosis, or blood clots,which can possibly lead to strokes and other complications. During manyof the procedures to implant such currently available devices, bloodtransfusions are required due to excessive bleeding by the patient.Additionally, the surgery upon the heart may lead to Right HeartFailure, which is the leading cause of early death in present patientsreceiving implanted left ventricle assist devices. Presently availableleft ventricle assist devices, which are connected to the aorta of thepatient, can lead to unbalanced blood flow to certain branch vessels ascompared to others. For example, the blood flow from the aorta tocertain blood vessels that branch off the aorta, such as the coronary orcarotid arteries, may be diminished. Lastly, present LVADs, which areimplanted without chest surgery (percutaneous LVADs), are typically onlyused for a relatively short period of time, generally on the order of7-10 days, whereas it would be desirable for a long-term treatment—onthe order of months or even years—for patients with severe chroniccongestive heart failure who cannot withstand conventional surgery.

Accordingly, prior to the development of the present invention, therehas been no method and apparatus for long-term assisting the leftventricle of the heart to pump blood which: does not require surgeryupon the heart itself; does not require long conduits, or fluidpassageways, to connect the device to the heart; supplies a balanced andnormal blood flow, or physiologic blood supply, to branch vessels, suchas the coronary and carotid arteries; can be implanted without the useof general anesthesia; can be implanted and used for a long period oftime; and can be transluminally delivered and implanted in a cardiaccatheterization lab setting with minimal blood loss and relatively lowrisk of morbidity and mortality. Therefore, the art has sought a methodand apparatus for long term assisting the left ventricles of the heartto pump blood, which: does not require surgery, or incisions upon theheart itself; does not require open chest surgery; does not requirelengthy conduits, or fluid passageways, through which the blood mustflow and be pumped through; is believed to provide a normal and balancedblood flow or physiologic blood supply, to branch vessels such as thecoronary and carotid arteries; can be transluminally delivered andimplanted without the use of general anesthesia; can be implanted andused for a long period of time; and can be implanted in a cardiaccatheterization lab setting by a cardiologist with minimal blood lossand relatively low risk of morbidity and mortality.

SUMMARY OF THE INVENTION

In accordance with the present invention, the foregoing advantages arebelieved to have been achieved through the present long-term leftventricle assist device for assisting a left ventricle of a heart inpumping blood. The present invention may include a transluminallydeliverable pump and a deliverable support structure, which may beimplanted in the catheterization laboratory.

The method and apparatus for assisting the left ventricle of the heartto pump blood of the present invention, when compared to previouslyproposed methods and apparatus, is believed to have the advantages of:not requiring surgery, or incisions, upon the heart itself; notrequiring the use of lengthy conduits, or fluid passageways, throughwhich blood must pass through and be pumped through; supplying a normaland a balanced blood flow, or physiologic blood supply, to branchvessels, such as the coronary and carotid arteries; can be implantedwithout the use of general anesthesia; not requiring a chest surgery;can be implanted and used for a long period of time; and can betransluminally implanted in a cardiac catheterization lab setting withminimal blood loss and relatively low risk of morbidity and mortality.

BRIEF DESCRIPTION OF THE DRAWING

In the drawing:

FIG. 1 is a front view of a current left ventricle assist device,illustrating its location within a patient's body;

FIG. 2 is a partial cross-sectional view of a heart, to illustrate itsfunctions and anatomy;

FIG. 3 is a partial cross-sectional view of the left ventricle assistdevice of the present invention in a first transluminal deliveryconfiguration, the device being enlarged for clarity;

FIG. 4 is a partial cross-sectional view of the left ventricle assistdevice in accordance with the present invention in a second deployedconfiguration;

FIG. 4A is a partial cross-sectional view of another embodiment of theleft ventricle assist device in accordance with the present invention ina second deployed configuration;

FIG. 5 is perspective view of a power connection for the left ventricleassist device in accordance with the present invention;

FIG. 6 is a perspective view of another embodiment of a power connectionfor the left ventricle assist device in accordance with the presentinvention;

FIG. 7 is a side view of a connection flange in accordance with thepresent invention;

FIG. 8 is a front view of the connection flange of FIG. 7;

FIG. 9 is a partial cross-sectional view of an embodiment of the leftventricle assist device in accordance with the present invention,similar to that of FIGS. 3 and 4, including a one-way valve;

FIG. 10 is a partial cross-sectional view of the left ventricle assistdevice of the present invention being deployed in the ascending aorta;

FIG. 11 is a partial cross-sectional view of another embodiment of theleft ventricle assist device of the present invention in a firsttransluminal delivery configuration, the device being enlarged forclarity; and

FIG. 12 is a partial cross-sectional view of another embodiment of theleft ventricle assist device in accordance with the present invention ina second deployed configuration;

While the invention will be described in connection with the preferredembodiments shown herein, it will be understood that it is not intendedto limit the invention to those embodiments. On the contrary, it isintended to cover all alternatives, modifications, and equivalents, asmay be included within the spirit and the scope of the invention asdefined by the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In FIG. 1, a currently available left ventricle assist device 70 isshown to include: an inflow conduit, or fluid passageway, 71, disposedbetween the lower portion of the left ventricle 72 of heart 73 and adevice housing 74; and an outflow conduit 75 disposed between the devicehousing 74 and a portion of the ascending aorta 76 of heart 73. Device70 also includes an associated source 77 of suitable power and relatedsensors 78, all operatively associated with device housing 74 in a knownmanner.

As previously discussed, the implantation of left ventricle assistdevice 70 within the body 79 requires surgery incisions upon the heart73, where the inflow conduit 71 is attached to heart 73. As alsopreviously discussed, although left ventricle assist devices presentlyin use, such as device 70 illustrated in FIG. 1, do provide the bestpresently available level of care for patients awaiting a hearttransplant, by assisting the patient's heart 73 to pump his or her bloodthrough the patient's body, such currently available left ventricleassist devices are believed to have certain previously discusseddisadvantages. These disadvantages relate to: the use of the lengthyconduits, or flow passageways, and the particularly long outflow conduit75; and the requirement of an actual incision and surgery upon the heartmuscle, including blood loss and use of general anesthesia in order toconnect the inflow conduit to the left ventricle 72 of heart 73. In theregard, some devices also include implanting components thereof withinleft ventricle 72 of heart 73. The currently available left ventricleassist devices, such as device 70 of FIG. 1, although suffering from thepreviously described disadvantages, is also an acceptable device forhelping patients who may not need a heart transplant, or cannotwithstand the rigors of such a surgery, but who may similarly benefitfrom having assistance provided in pumping blood through their body.

With reference to FIGS. 3-4, a left ventricle assist device 80 inaccordance with the present invention is illustrated in conjunction witha patient's heart 73. Before describing the left ventricle assist device80 of the present invention, a brief description of the functioning ofheart 73 and associated arteries will help in understanding the leftventricle assist device 80 as will be hereinafter described.

In general, the heart 73 consists of two pumps lying side by side. Eachpump has an upper chamber, or atrium, and a lower chamber, or ventricle,as will hereinafter be described. Heart 73 functions to provide aperson's body 79 (FIG. 1) with a continuous supply of blood asillustrated by arrows 81 throughout FIGS. 2-6. In general, the rightside of heart 73 receives “used” blood from the veins (not shown) of aperson's body, and this blood is pumped to the lungs (not shown) of theperson's body to be oxygenated. The oxygen-rich blood from the lungs isthen returned to the left side of the heart, which pumps it through thevarious arteries. Heart 73 requires its own supply of blood to keep itbeating. Oxygen-rich blood is pumped to the chambers, or ventricles, ofthe heart through the coronary arteries, as will be hereinafterdescribed. Once the blood has been used, it is returned to the rightside of heart 73 through a network of veins.

The functioning of these elements of heart 73 may be described inconnection with FIGS. 2 and 5. Deoxygenated blood flows from veins, suchas vein 82 into the right atrium, or right upper chamber, 85 of heart73, as illustrated by arrows 81′. Deoxygenated blood 81′ then flowsthrough the one-way tricuspid valve, or right atrioventricular valve,86′ into the right lower chamber, or right ventricle, 86 of heart 73.Contraction of the muscle surrounding right ventricle 86 pumps the bloodthrough the semilunar valve, or pulmonary valve 87, and along thepulmonary arteries 88 through the lungs (not shown), where thedeoxygenated blood 81′ receives oxygen. The ascending pulmonary arteryis designated 89, from which pulmonary arteries 88 branch. Oxygenatedblood, as represented by arrows 81″ flows from the lungs into the leftupper chamber, or left atrium, 90 and then passes downwardly throughmitral valve, or left atrioventricular valve, 91 into the left lowerchamber, or left ventricle, 72. Muscle surrounding the left ventricle 72contracts and pumps the blood 81″ through the semilunar valve, or aorticvalve, 92 into the aorta, or ascending aorta, 76, and descending aorta98. The oxygenated blood 81″ is then circulated through the body'sarteries and ultimately returned as deoxygenated blood 81′ to the rightside of heart 73 as previously described. As previously described,oxygen-rich blood 81″ is pumped to the left and right sides of heart 73through the left coronary artery 95 and right coronary artery 96. Aspreviously described, once the oxygen-rich blood 81″ has been used, theblood is returned to the right side of the heart through a network ofveins 97.

With reference to FIGS. 3 and 4, the left ventricle assist device 80 ofthe present invention includes: a pump 110 which is percutaneously andtransluminally delivered to a portion of the descending aorta 98 (FIGS.2 and 4) of a patient 79 via the femoral artery 10 (FIG. 3) of a patient79; and a transluminally deliverable support structure 120 whichsecures, or anchors, pump 110 within the descending aorta 98. Leftventricle assist device 80 is disposed within a portion of thedescending aorta 98, preferably in a central portion of the descendingaorta 98. Pump 110 pumps, or pulls, blood 81″ downward from theascending aorta 76, and thereafter the oxygenated blood 81″ from leftventricle 72 is then circulated through the various arteries of thepatient's body.

Still with reference to FIGS. 3 and 4, pump 110 is a rotary pump andpreferably is an axial flow pump 111 having first and second ends 112,113, and pump 110 is preferably disposed within a housing 114. At leastone spiral vane, or impeller, 115 is disposed within housing 114.Housing 114 may be approximately 20 French diameter in size, althoughother sizes may be selected. Pump 110 is preferably powered by a motor116, such as an electric motor 116′, which rotates impeller 115.Impeller 115 may be mounted on bearings, or magnetically levitated, forrotation within housing 114. A power wire 117 is associated with motor116, and as will hereinafter described in greater detail, it extendsfrom left ventricle assist device 80 to a point at which it may beassociated with a power source, such a battery (not shown). Housing 114may be provided with a top cover, or inflow cage, 118, which permits thepassage of blood 81″ into housing 114, as it is drawn into, pumped, orpulled into housing 114 by the rotation of impeller 115. Housing 114 ispreferably made of a suitable metallic or plastic material, such asstainless steel, which is a bio-compatible material. Alternatively,other bio-compatible materials, including plastic materials, having therequisite strength and bio-compatibility characteristics which permitthe desired use in a person's aorta may be utilized. If pump 110 is anaxial flow pump 111, impeller 115 would rotate about the longitudinalaxis 119 of housing 114.

Still with reference to FIGS. 3 and 4, support structure 120 of leftventricle assist device 80 includes a plurality of support members 121associated with pump 110, which are preferably associated with housing114. Support members 121 may be secured to the outer surface, or outerwall surface, 114′ of housing 114 in any suitable manner, such as bywelding or adhesive bonding. Support structure 120 supports pump 110within the descending aorta 98, preferably in a generally, centrallyspaced relationship from the interior wall surface 98′ of descendingaorta 98. As will be hereinafter described in greater detail, supportstructure 120 anchors pump 110 within descending aorta 98 for long-termuse to assist the pumping of blood 81″ from ascending aorta 76downwardly through descending aorta 98. At least two support members, orstruts, 121 are disposed toward the upper end 112 of pump 110 and towardthe lower end 113 of pump 110. Preferably, at least three supportmembers, or struts 121, are substantially equidistantly disposed aroundeach of the upper and lower ends 112, 113 of pump 110. Preferably, thesupport members 121 have are formed of a suitable bio-compatiblematerial, such as stainless steel. Alternatively, other bio-compatiblematerials, including plastic materials, having the requisite strength,expansion or spring, and bio-compatible characteristics to function inthe manner hereinafter described in a person's aorta 98 may also beutilized. As shown in FIG. 3, the support structure 120, or plurality ofsupport members 121 are disposed in a first configuration forpercutaneous transluminal delivery to the desired portion of thedescending aorta 98, as will be hereinafter described. In the firstconfiguration, support members 121 are disposed substantially adjacentthe outer wall surface 116 of housing 114, and are disposedsubstantially parallel to the longitudinal axis 119 of housing 114. Inthis first configuration, the overall diameter of pump 110, housing 114,and support structure 120 is reduced to permit the percutaneoustransluminal delivery of the left ventricle assist device 80 through thefemoral or iliac artery 10 of the patient to the desired location withinthe descending aorta 98.

The support members, or struts 121, may be disposed in the configurationshown in FIG. 3 as by a sheath 130 or annular bands (not shown), whichmay be subsequently removed, or alternatively, the struts, or supportmembers 121, when initially attached to the outer wall surface 114′ ofhousing 114, have the disposition shown in FIG. 3.

Upon the left ventricle assist device 80 being positioned within thedesired portion of the descending aorta 98, the support members, orstruts, 121, have a second, expanded configuration wherein the outerends 122 of the support members 121 contact the inner wall surface 98′of descending aorta 98. The second disposition of the support members121 shown in FIG. 4 may be achieved in a variety of ways. For example,the support members 121 may be formed as leaf springs, or springmembers, wherein the support members 121 are biased to spring outwardlyinto the configuration shown in FIG. 4. If support members 121 are inthe form of leaf springs which bias outwardly toward descending aorta98, they may be initially restrained into the configuration shown inFIG. 3, by a sheath 130 or band-like member, as previously described,which may be removed when left ventricle assist device 80 has beendelivered to its desired location within the descending aorta 98,whereby the support members, or struts, 121 would move outwardly intothe configuration illustrated in FIG. 4. Alternatively, support members121 could be formed of a material, such as nitinol, whereby the supportmembers 121 would initially have the configuration shown in FIG. 3, andupon being heated by the blood flowing within aorta 98 would springoutwardly into the configuration illustrated in FIG. 4.

Other devices and structures could be utilized for support structure120, provided they permit the percutaneous transluminal delivery of theleft ventricle assist device 80, and that after such delivery, thesupport structure 120 permits the disposition of the left ventricleassist device within the descending aorta for long-term use, as shown inFIG. 4. By use of the terms “long term” and “long-term use”, it is meantto be more than the relatively short period of time that conventionalpercutaneous LVADS are used for (e.g. greater than 7-10 days, aspreviously described), and preferably on the order of at least a monthand perhaps even a year or more. For example, a self-expanding stent200, or stents, as are known in the art could be used for supportivestructure 120, to support pump 110 in a substantially, centrally spacedrelationship from the interior wall surface 98′ of aorta 98, as shown inFIGS. 11 and 12. The stent, or stents, 200, schematically shown in FIGS.11 and 12, could have pump 110 centrally disposed therein with supportmembers, or struts 121, being attached to the interior of the stent asshown in FIG. 11. The stent 200 with the pump, and struts disposedtherein, could be compressed and disposed within a sheath 130, ashereinafter discussed and transluminally delivered as seen in FIGS. 11and 12, in a manner similar to and as shown as described with referenceto FIG. 3. Upon removal of sheath 130 the self-expanding stent 200 withpump 10 and struts 121 would expand outwardly as seen in FIG. 12,similar to FIG. 4, whereby the pump 110 would be supported in agenerally centrally spaced relationship from the interior wall surface98′ of aorta 98.

With reference to FIGS. 3 and 4, preferably, the outer end 122 of atleast one strut 121, and preferably each of the outer ends of thesupport members, or struts, 121 are provided with an anchor element,such as a small hook 123, or similar structure, which serves to anchoreach of the struts 121 at the desired location within descending aorta98. If desired, a plurality of anchor elements may be used. Preferably,the left ventricle assist device 80 of the present invention isinitially sheathed in a sheath 130 of approximately 22 to 23 French sizein diameter in its undeployed configuration, as show in FIG. 3. If thestruts 121 are of a spring-type design, the sheath 130 retains thesupport members 121 in the desired configuration illustrated in FIG. 3.Housing 114 preferably has a diameter of approximately 20 French. Thestrut system, or struts 121, may also be deployed as a separate unitfrom the pump and initially deployed, and thereafter the pump 110 canthen be deployed into the center of the strut system utilizing a lockingmechanism, so that the pump may be removed and replaced at a later dateso as to allow the ability to replace the pump if it should fail.Additionally, two or more pumps 110, 110′ may be placed in parallel inthe descending aorta with one pump being designed in a more cranialposition and the other pump in a more caudal position, so as to allowfor redundancy of the pumps in case one fails and to allow for morepumping capability while utilizing the same French size sheath fordelivery, as shown in FIG. 4A.

It should be apparent to one of ordinary skill in the art that otherpumps 110 could be utilized in lieu of axial flow pump 111, providedpump 110 is bio-compatible and capable of operating in the environmentof the body, specifically the aorta, and able to pump blood 81″. Pump110 may be powered by an implanted power device, or transformer, and mayreceive electric power from either an implanted power source or from asource of power located outside the patient's body 79. It should bereadily apparent to one of ordinary skill that if desired other types ofpower could be utilized to power pump 110, such as hydraulic power orother types of power sources. The implanted power device, not shown,could be a conventional battery or a plutonium, or other nuclearmaterial, power source.

With reference to FIG. 5, a power connection 135 for left ventricleassist device 80 is shown, with power wire 117 extending from the leftventricle assist device 80 being associated with a tubular shaped graft131. The power wire 117 extends into the interior 132 of graft 131 andpasses outwardly of the graft 131 through the wall surface of the graft131 and includes a portion 118 of power wire 117 extending outwardlyfrom graft 131. As will be hereinafter described in greater detail, thegraft 131 is connected or anastamosed to the patient's femoral artery 10(FIG. 3), or other suitable body passageway, and it is desirable thatblood flowing within graft 131 does not leak from graft 131 at thelocation through which power wire 117 passes through graft 131. Graft131 may be formed as a woven Dacron graft, as are known in the art. Toprovide the desired sealing about power wire 117, the individual wires117′ forming the composite power wire 117 may be woven into the interiorsurface of graft 131 and passed outwardly through the wall surface ofthe graft 131 at which point the individual wires 117 are recombinedinto the portion 118 of power wire 117 extending outwardly of graft 131.Graft 131 may have an approximate length of 2-3 cm. The external portion118 of power wire 117 may then be connected to a transcutaneous energytransmission coil (not shown), which may be placed just under the skinin the patient's thigh region. The transcutaneous energy transmissioncoils may then receive electrical energy from another transcutaneousenergy transmission coil, or antenna, worn by the patient in closeproximity or remotely to the implanted transcutaneous energytransmission coil. Thus, power may be supplied to pump 110 via powerwire 117. Alternatively, power wire 117 could pass through Dacron graft131 or the vessel wall itself and a suitable bio-compatible sealantcould be used to provide the requisite seal between power wire 117 andgraft 131.

Alternatively, the power wire 117 could be surrounded by standard feltmaterial, and the power wire 117 is exteriorized through the skin midwaydown the patient's thigh, approximate the vastous medialus or lateralusmuscle. The exiting power wire 117, or portion 118, could then beconnected directly to an external battery and a controller device (notshown). The controller (not shown) could be a standard power deliverydevice, delivering proper wattage to allow for a variable range ofoperation of pump 110, whereby pump 110 could pump blood at a rate offrom approximately 0.5 liters/minute to as high as 5 liters/minute,depending upon the needs of the patient. The battery may be connected tothe controller or incorporated within it, with one primary battery and asecond auxiliary battery being utilized. The controller and batteriescould be worn on the patient's belt or up on a holster-type system, orstrapped to the patient's leg via a Velcro type attachment means, orother suitable attachment structure. The transcutaneous energytransmission coil could also be operated to provide varying amounts ofpower to pump 110 so as to also provide for the variable pumping ofblood at a rate of from approximately 0.5 liters/minute to as high as 5liters/minute.

The controller for either system could vary pump speed either insynchronization with the heart rhythm or paced rhythm, or out ofsynchronization with the heart rhythm or paced rhythm to provide optimalflow to the body. The device controller may also have the ability tosense the native electrocardiogram of the patient or the paced rhythm,and thus vary pump speed based upon it, and it may also communicatedirectly or indirectly with an implanted pacemaker, or defibrillatordevice, to optimize flow in this manner. The device controller may alsobe able to sense when the patient is supine or lying down and decreaseor increase overall pump speed to compensate for decreased need whilesupine. The device controller may also sense other physiologicparameters such as bioimpedence, body motion or cardiac performanceparameters and adjust pump speed to optimize flow of blood to the body.

The method, or procedure to transluminally implant the LVAD 80 of thepresent invention may include some, or all, of the following steps.First, the patient is prepared in a catheterization lab in a standardfashion. Under conscious sedation, local anesthesia is applied to thefemoral area, similar to the manner in which a standard heartcatheterization is performed. A small 3 cm incision is made in thevertical plane overlying the femoral artery 10, just below the inguinalligament. The femoral artery is exposed, and may then be entered by theSeldinger technique over a guide-wire and is successively dilated toallow entry of a sheath 140, having a preferred diameter of 23 French(FIG. 3). The sheath 140 is then passed over a guide-wire and thenplaced into position in the descending aorta 98, with the tip 141 (FIG.3) in the mid thoracic aorta, approximately 4 cm below the take off ofthe left subclavian artery. The sheath 140 is then de-aired. Sheath 140contains at its external end, outside the patient's body, a one-wayvalve and a side arm for de-airing. The LVAD 80 is then passed throughthe one-way valve into the sheath 140 to the tip 141 at the mid thoracicarea. The passage of the LVAD 80 through the sheath 140 is made possiblewith an obturator (not shown). As the obturator is held in place, thesheath 130 is then withdrawn, which in the case of a spring type supportstructure 120, the support members, or struts 121 then spring open andanchor the pump 110 in the descending aorta 98, or alternatively, ifsupport structure 120 is a self-expanding stent 200, stent 200 springsopen and anchors the pump 110 in the aorta 98. The obturator is thenremoved, and the sheath 140 is then pulled back with the power wire 117still passing through, or disposed within, the sheath 140.

The graft 131 (FIG. 5) that contains the transarterial wire system, orpower connection 135, is then passed through the one-way valve into thesheath 140, and the sheath 140 is successively withdrawn until thesheath exits the femoral or iliac artery. Just prior to it exiting thefemoral, or iliac, artery, a clamp is placed proximal to the entry siteto prevent excessive bleeding. Thereafter, a small section approximately1.5 cm of the femoral artery is excised, and the graft 131 isanastamosed in an end-to-end fashion in an interposition technique tothe femoral or iliac artery. It is then de-aired. This leaves thetransarterial wire, or portion 118 (FIG. 5) of wire 117 external to theartery 10, which is then tunneled to a drive line exit site or tunneledunder the skin to a transcutaneous energy transmission coil, which isplaced under the skin. The skin is then closed with suture.

Alternatively, with reference to FIGS. 6-9, after the sheath 140 isremoved, a clamp is applied to prevent excessive bleeding. At the siteof entry of the power wire 117 into the artery 10, a tubular graft, or asmall flange member 160 is placed via a small delivery tool, which ispassed over the power wire 117. The graft, or flange, 160 is put intoposition and the small delivery tool is removed and any excessivebleeding is observed. The flange member 160 may be made of either Dacrongraft material or an inert polyurethane compound, or otherbio-compatible material, and flange 160 may also be a thrombin plug witha central hole 161 to allow passage of the wire 117. The flange member160 is preferably two small, circular shaped members joined by a centralportion 162, which has a central hole 161 through which the wire passes.The flange 160 is preferably 25 French in diameter, whereby it is largeenough to occlude the hole in the artery 10, which was made by the largesheath 140. This flange system allows for externalization of the powerwire 117 from the artery 10 without excessive bleeding while preventingformation of an arterial fistula. The power wire is now external to theartery 10 and can be attached to an internal implanted transcutaneousenergy transmission coil or exteriorized through a drive line aspreviously described.

After access to the artery 10 is gained, anti-coagulation with a shortterm intravenous anti-coagulant is provided during the procedure, andimmediately thereafter, until long-term oral anti-coagulation can beinstituted, if needed.

With reference to FIG. 9, a figure similar to FIG. 4, the left ventricleassist device 80 is provided with a one-way valve 170, and is showndisposed in the descending aorta 98. The same reference numerals areused for the same components shown and described in connection withFIGS. 3 and 4. One-way valve 170 may be provided to prevent backflow ofblood 81″ from flowing upwardly back into descending aorta 98. One-wayvalve 170 may be provided in any suitable manner, such as by supportingone-way valve 170 by a strut system 171 associated with housing 114.Strut system 171 may include a plurality of strut members 172 which maybe deployed in a similar manner to strut members 121 of strut system 120to bring the circumferential end, or lip, 172 of one-way valve 170 intoa sealing relationship with the interior surface 98′ of descending aorta98. The other, smaller diameter circumferential end, or lip, 174 ofone-way valve 170 is shown in FIG. 9 disposed in its sealed relationshipwith respect to housing 114, whereby backflow of blood 81″ upwardly intodescending aorta 98 is prevented. As blood 81″ is pumped to flowdownwardly into descending aorta 98, one-way valve 170 may open as shownby dotted lines 170′, whereby one-way valve 170 opens as shown in thedirection of arrows 175, whereby the circumferential lip 174 of one-wayvalve 170 moves outwardly from housing 114 to permit blood 81″ to flownot only through pump 110, but from outside housing 114 and intodescending aorta 98.

One-way valve 170 may be made of any suitable bio-compatible, orbiomaterial, including plastic materials, having the requisite strengthand bio-compatibility characteristics which permit the desired use in aperson's aorta and permits the function of one-way valve 170. Rigidbiomaterials, or flexible biomaterials may be utilized for theconstruction of one-way valve 170.

With reference to FIG. 10, the left ventricle assist device 80 of thepresent invention, having the same general construction as illustratedin connection with FIGS. 3 and 4 is shown disposed, not in thedescending aorta 98, but rather in the ascending aorta 76, withoxygenated blood 81″ being pumped by pump 110 from the left ventricle 72and outwardly into the aortic root, or ascending aorta, 76. In thisembodiment of the left ventricle assist device 80, the housing 114′ islengthened to include an inflow cannula 180, which may be provided witha plurality of openings, or ports, 181 formed in the side walls ofcannula 180. Similar ports 181 may also be provided in the upper end ofhousing 114′, which ports 181 assist in the passage of blood 81″ throughhousing 114′. As shown in FIG. 10, housing 114′ is anchored withinascending aorta 76 by a plurality of strut members 121, and housing 114′is disposed within aortic valve 92. When the left ventricle assistdevice 80, shown in FIG. 10, is deployed within the ascending aorta 76,the aortic valve 92 functions as the one-way valve which may beprovided, as discussed in connection with the embodiment of LVAD 80 ofFIG. 9. It is believed that by disposing the left ventricle assistdevice 80 within the ascending aorta 76, direct unloading of the leftventricle 72 will be provided, so that more efficient afterloadreduction may be accomplished. It is also believed that deployment ofthe left ventricle assist device in the ascending aorta 76 will alsopermit better perfusion of the cerebral circulation. In the embodimentof left ventricle assist device 80 of FIG. 10, power wire 117′ may beassociated with the upper, or first end, 112 of pump 110.

Alternatively, rather than transluminally implanting the LVAD 80 of thepresent invention through the femoral artery, as previously described,LVAD 80 may be transluminally implanted and delivered through the leftor right subclavian artery, and the power source or battery andcontroller may be placed in the pectoral area of the patient. This typeof implant technique would be similar to the implantation of a cardiacpacemaker or defibrillator, with the exception that access would beobtained through the subclavian artery, rather than the subclavian vein.The power source, and/or its controller, may be incorporated in a devicesuch as a cardiac pacemaker or defibrillator, if used in this manner.

Alternatively, if desired, the pump 110 and support structure 120,including support members 121, could be designed whereby pump 110 andsupport structure 120 could be removed with a catheter based removaldevice (not shown) which could collapse support members 121 anddisengage them from their anchored configuration to permit the removalof them and pump 110, if desired, such as to replace or repair pump 110.Such a catheter based removal device could be similar to those presentlyused with inferior vena cava filters.

The present invention has been described and illustrated with respect toa specific embodiment. It will be understood to those skilled in the artthat changes and modifications may be made without departing from thespirit and scope of the invention as set forth in the appended claims.

1. A left ventricle assist device adapted to be delivered to, andimplanted within, a portion of an aorta, comprising: at least onetransluminally deliverable pump; and a transluminally deliverablesupport structure for securing the at least one pump within the portionof the aorta for long-term use, wherein the support structure includes aplurality of support members associated with the at least one pump, andthe plurality of support members are a plurality of struts, each struthaving an outer end, and at least one of the struts has at least oneanchor element adjacent the outer end of the strut to anchor the strutto a portion of the aorta.
 2. The left ventricle assist device of claim1, wherein the at least one anchor element is a hook.
 3. The leftventricle assist device of claim 1, wherein the at least one pump is arotary pump.
 4. The left ventricle assist device of claim 3, wherein theat least one pump is an axial flow pump disposed within a housing, andincludes a rotatable impeller and a motor.
 5. The left ventricle assistdevice of claim 4, wherein the motor is an electric motor which receiveselectricity from a power wire in an electrical transmitting relationshipwith the motor.
 6. The left ventricle assist device of claim 5, whereinthe power wire has first and second ends and an intermediate portion,the first end of the power wire is associated with the motor and thesecond end of the wire is associated with a power source; and a portionof the intermediate portion of the power wire is associated with agraft, adapted to be disposed within a body passageway, the portion ofthe power wire passing through the graft.
 7. The left ventricle assistdevice of claim 6, wherein the graft is a tubular graft.
 8. The leftventricle assist device of claim 7, wherein the tubular graft has firstand second ends and a wall surface extending between the first andsecond ends of the tubular graft, and the portion of the power wirepasses through the wall surface of the graft.
 9. The left ventricleassist device of claim 8, wherein the power wire is formed of aplurality of individual wires, and the plurality of individual wires arewoven into the wall surface of the graft.
 10. The left ventricle assistdevice of claim 7, wherein the tubular graft is a flange member, adaptedto be disposed within a wall of the body passageway, and the portion ofthe power wire passes through the flange member.
 11. The left ventricleassist device of claim 1, including a one-way valve adapted to preventundesired backflow of blood into a portion of the aorta.
 12. The leftventricle assist device of claim 1, including an inflow cannula having aplurality of ports associated with the at least one pump.
 13. A leftventricle assist device adapted to be delivered to, and implantedwithin, a portion of an aorta, comprising: at least one transluminallydeliverable pump; and a transluminally deliverable support structure forsecuring the at least one pump within the portion of the aorta forlong-term use, wherein the support structure is a self-expanding stent,and the at least one pump is substantially, centrally disposed withinthe stent by at least one strut member attached to the stent.
 14. Theleft ventricle assist device of claim 13, wherein the at least one pumpis a rotary pump.
 15. The left ventricle assist device of claim 14,wherein the at least one pump is an axial flow pump disposed within ahousing, and includes a rotatable impeller and a motor.
 16. The leftventricle assist device of claim 15, wherein the motor is an electricmotor which receives electricity from a power wire in an electricaltransmitting relationship with the motor.
 17. The left ventricle assistdevice of claim 16, wherein the power wire had first and second ends andan intermediate portion, the first end of the power wire is associatedwith the motor and the second end of the wire is associated with a powersource; and a portion of the intermediate portion of the power wire isassociated with a graft, adapted to be disposed within a bodypassageway, the portion of the power wire passing through the graft. 18.The left ventricle assist device of claim 17, wherein the graft is atubular graft.
 19. The left ventricle assist device of claim 18, whereinthe tubular graft has first and second ends and a wall surface extendingbetween the first and second ends of the tubular graft, and the portionof the power wire passes through the wall surface of the graft.
 20. Theleft ventricle assist device of claim 19, wherein the power wire isformed of a plurality of individual wires, and the plurality ofindividual wires are woven into the wall surface of the graft.
 21. Theleft ventricle assist device of claim 18, wherein the tubular graft is aflange member, adapted to be disposed within a wall of the bodypassageway, and the portion of the power wire passes through the flangemember.
 22. The left ventricle assist device of claim 13, including aone-way valve adapted to prevent undesired backflow of blood into aportion of the aorta.
 23. The left ventricle assist device of claim 13,including an inflow cannula having a plurality of ports associated withthe at least one pump.
 24. A method for providing long-term assistanceto a left ventricle of a heart, having an aorta, to pump blood,comprising the steps of: providing at least one transluminallydeliverable pump which is associated with a transluminally deliverablesupport structure, wherein the support structure includes a plurality ofsupport members associated with the at least one pump, and the pluralityof support members are a plurality of struts, each strut having an outerend, and at least one of the struts has at least one anchor elementadjacent the outer end of the strut; transluminally delivering the atleast one pump and the support structure to a desired location withinthe aorta; anchoring the at least one anchor element into the aorta, toanchor the at least one pump to the aorta; supplying power to the atleast one pump; and operating the at least one pump to pump bloodthrough the aorta.
 25. The method of claim 24, including the step ofutilizing a hook as the at least one anchor element.
 26. The method ofclaim 24, including the step of utilizing a rotary pump as the at leastone pump.
 27. The method of clam 26, including the step of providing theat least one pump with a motor which is an electric motor, including thestep of providing electricity to a power wire in an electricaltransmitting relationship with the motor.
 28. The method of claim 27,wherein the power wire has first and second ends and an intermediateportion, including the steps of associating the first end of the powerwire with the motor and associating the second end of the wire with apower source; associating a portion of the intermediate portion of thepower wire with a graft; disposing the graft within a body passageway;and passing the portion of the power wire through the graft.
 29. Themethod of claim 28, including the step of utilizing a tubular graft asthe graft.
 30. The method of claim 29, wherein the tubular graft hasfirst and second ends and a wall surface extending between the first andsecond ends of the tubular graft, including the step of passing theportion of the power wire through the wall surface of the graft.
 31. Themethod of claim 30, wherein the power wire is formed of a plurality ofindividual wires, including the step of weaving the plurality ofindividual wires into the wall surface of the graft.
 32. The method ofclaim 29, wherein the tubular graft is a flange member, including thesteps of disposing the flange member within a wall of the bodypassageway, and passing the portion of the power wire through the flangemember.
 33. The method of claim 24, including the step of providing theat least one pump with a one-way valve to prevent undesired backflow ofblood into the aorta.
 34. The method of claim 24, including the step ofproviding the at least one pump with an inflow cannula having aplurality of ports.
 35. The method of claim 24, including the step ofvarying the rate at which the at least one pump, pumps blood.
 36. Themethod of claim 35, including the step of varying the rate either insynchronization with a rhythm of the heart or out of synchronizationwith the rhythm of the heart.
 37. A method for providing long-termassistance to a left ventricle of a heart, having an aorta, to pumpblood, comprising the steps of: providing at least one transluminallydeliverable pump which is associated with a transluminally deliverablesupport structure, wherein the support structure is a self-expandingstent; disposing the at least one pump substantially, centrally withinthe stent by at least one strut member attached to the stent;transluminally delivering the at least one pump and the supportstructure to a desired location within the aorta; anchoring the at leastone anchor element into the aorta, to anchor the at least one pump tothe aorta; supplying power to the at least one pump; and operating theat least one pump to pump blood through the aorta.
 38. The method ofclaim 37, including the step of utilizing a hook as the at least oneanchor element.
 39. The method of claim 37, including the step ofutilizing a rotary pump as the at least one pump.
 40. The method of clam39, including the step of providing the at least one pump with a motorwhich is an electric motor, including the step of providing electricityto a power wire in an electrical transmitting relationship with themotor.
 41. The method of claim 40, wherein the power wire has first andsecond ends and an intermediate portion, including the steps ofassociating the first end of the power wire with the motor andassociating the second end of the wire with a power source; associatinga portion of the intermediate portion of the power wire with a graft;disposing the graft within a body passageway; and passing the portion ofthe power wire through the graft.
 42. The method of claim 41, includingthe step of utilizing a tubular graft as the graft.
 43. The method ofclaim 42, wherein the tubular graft has first and second ends and a wallsurface extending between the first and second ends of the tubulargraft, including the step of passing the portion of the power wirethrough the wall surface of the graft.
 44. The method of claim 43,wherein the power wire is formed of a plurality of individual wires,including the step of weaving the plurality of individual wires into thewall surface of the graft.
 45. The method of claim 42, wherein thetubular graft is a flange member, including the steps of disposing theflange member within a wall of the body passageway, and passing theportion of the power wire through the flange member.
 46. The method ofclaim 37, including the step of providing the at least one pump with aone-way valve to prevent undesired backflow of blood into the aorta. 47.The method of claim 37, including the step of providing the at least onepump with an inflow cannula having a plurality of ports.
 48. The methodof claim 37, including the step of varying the rate at which the atleast one pump, pumps blood.
 49. The method of claim 48, including thestep of varying the rate either in synchronization with a rhythm of theheart or out of synchronization with the rhythm of the heart.